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Life Sciences & Healthcare

Portugal

Health, medical devices, pharmaceutics area and the new branches of science such as biotechnology raise several legal issues and show a high complexity and specificity.

The diversity of entities involved in this sector, the existing regulation and the own operation of the market require from the lawyers a strong knowledge of the specificities of this area. Our team works in particular within the following areas:

  • Regulation
  • Licensing
  • Finance / Mergers and acquisitions
  • Business restructuring
  • Litigation
  • Clinical research
  • Distribution
  • Patents protection and enforcement
  • Labelling
  • Safety and Health
  • Competition
  • Public offers
  • Environment
  • Immigration

We have a multidisciplinary team with a strong curriculum in pharmaceutical area and well positioned to give an answer to the several intervening players in this sector.

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Radivoje Petrikić
15/12/2015
CMS Glob­al Lifes­ci­ences For­um 2015
Shap­ing the fu­ture through in­nov­a­tion and col­lab­or­a­tion
18/05/2018
EU Product Li­ab­il­ity Dir­ect­ive still an ad­equate tool, ac­cord­ing to...
On 7 May 2018, the European Com­mis­sion pub­lished its fifth re­port on the per­form­ance of the EU Product Li­ab­il­ity Dir­ect­ive (Dir­ect­ive/85/374/EEC) in the mem­ber states. The dir­ect­ive in­tro­duced the concept of strict li­ab­il­ity for pro­du­cers of de­fect­ive products.
17/04/2018
NGOs can ask the Com­mis­sion to re­view its de­cision on ge­net­ic­ally...
The Gen­er­al Court de­cided in its de­cision of 14 March 2018 that non-gov­ern­ment­al or­gan­iz­a­tions (“NGOs”) can ask the Com­mis­sion to re­view its de­cision on au­thor­iz­ing the pla­cing on the mar­ket of ge­net­ic­ally mod­i­fied food and feed.
25/01/2018
European Com­mis­sion as­sesses ad­equacy of Gen­er­al Food Law in food...
In an eval­u­ation of the EU le­gis­lat­ive frame­work for the 2002 Gen­er­al Food Law Reg­u­la­tion (GFLR), the European Com­mis­sion has found that this frame­work ap­pears to ad­dress most cur­rent trends, such as growth, com­pet­it­ive­ness and in­creased glob­al­isa­tion, but.
28/11/2017
REACH and Brexit – Some clar­ity gained but more cer­tainty re­quired
Sev­en­teen months after the UK Ref­er­en­dum on wheth­er to re­main in or leave the EU a num­ber of areas re­main un­cer­tain for busi­ness.   For the chem­ic­als in­dustry[i] whose products form an in­teg­ral part of our daily lives, the status of the corner­stone of the chem­ic­als.
06/11/2017
Brexit: State of play for Life Sci­ences com­pan­ies
With the UK pre­par­ing to leave the European Uni­on (EU) on 30 March 2019, life sci­ences com­pan­ies are plan­ning ahead for changes to the busi­ness and reg­u­lat­ory en­vir­on­ment. Dis­cus­sions at the EU Sum­mit on 19 Oc­to­ber 2017 primar­ily fo­cused on what are re­garded.
30/08/2017
The leg­al and reg­u­lat­ory chal­lenges of get­ting a bi­osim­il­ar product...
After a pharma view on bi­osim­il­ars was provided in the pre­vi­ous Ex­pert View column, a leg­al per­spect­ive is provided by Nick Beck­ett, man­aging part­ner at CMS Beijing and glob­al co-head of the firm­'s lifes­ci­ences sec­tor group.
20/07/2017
Entry in­to force of EU Clin­ic­al Tri­als Reg­u­la­tion post­poned to 2019
On 16 June 2017, the European Medi­cines Agency (“EMA”) pub­lished a press re­lease1 an­noun­cing the post­pone­ment of the entry in­to force of the EU Clin­ic­al Tri­als Reg­u­la­tion of 16 April 2016. 2 It was one of the top­ics at the June 2017 meet­ing of the EMA Man­age­ment.
23/06/2017
European Com­mis­sion in­vest­ig­ates po­ten­tial ex­cess­ive pri­cing of life-sav­ing...
On 15 May 2017, the European Com­mis­sion opened a form­al in­vest­ig­a­tion in­to the pri­cing of medi­cines. [1] The Com­mis­sion is in­vest­ig­at­ing wheth­er As­pen Pharma has been im­pos­ing ex­cess­ive pri­cing that con­sti­tutes an ab­use of dom­in­ant po­s­i­tion in vi­ol­a­tion of European.
22/06/2017
The Court of Justice of the EU held that the Bel­gian gen­er­al pro­hib­i­tion...
On 4 May 2017, the Court of Justice of the EU answered sev­er­al pre­ju­di­cial ques­tions sub­mit­ted by the Bel­gian tribunal of first in­stance re­gard­ing the ad­vert­ising of the ser­vices of dent­ists. In this judg­ment, the Court held that the Bel­gian le­gis­la­tion im­pos­ing.
21/06/2017
The Ver­dict - Round-up of cor­por­ate crime de­vel­op­ments across CMS
We are pleased to send our new is­sue of The Ver­dict, an at-a-glance round-up of re­cent leg­al de­vel­op­ments in re­la­tion to cor­por­ate crime. In this is­sue, the spot­light is on some sig­ni­fic­ant changes to anti-cor­rup­tion laws in the Czech Re­pub­lic, in­clud­ing.
02/05/2017
New reg­u­la­tion on med­ic­al devices
In­tro­duc­tion The cur­rent leg­al frame­work for med­ic­al devices in the European Uni­on is based on the fol­low­ing Dir­ect­ives, ad­op­ted in the 1990s: §  Dir­ect­ive 90/385/EEC, act­ive im­plant­able med­ic­al devices §  Dir­ect­ive 93/42/EEC, med­ic­al devices §  Dir­ect­ive.
06/03/2017
PIP-case: ECJ cla­ri­fies scope of no­ti­fied body’s re­spons­ib­il­it­ies...
In the PIP-case, a French man­u­fac­turer sup­plied thou­sands of wo­men with (al­legedly) de­fect­ive breast im­plants. Amongst oth­ers, pa­tients in Ger­many star­ted lit­ig­a­tion against the no­ti­fied body in ques­tion - TÜV Rhein­land (“Tuv”).
10/02/2017
In­dia Budget 2017 - 2018
On 1 Feb­ru­ary, Fin­ance Min­is­ter Ar­un Jait­ley presen­ted In­dia’s an­nu­al Uni­on Budget for 2017-2018 (the “Budget”) for the fisc­al year be­gin­ning 1 April 2017. The cent­ral aim in this year’s Budget ap­pears to fo­cus on the most vul­ner­able with in­creased spend­ing.
05/12/2016
ABS Reg­u­la­tion - Draft Bi­otech Sec­tor Stake­hold­er Guid­ance
Views are be­ing sought from in­ter­ested stake­hold­ers on European guid­ance for the bi­o­tech­no­logy sec­tor con­cern­ing the EU’s ac­cess to ge­net­ic re­sources and shar­ing of be­ne­fits from util­isa­tion le­gis­la­tion – namely the ABS Reg­u­la­tion.
07/10/2016
Gen­er­al Court of the EU con­firms the Lun­d­beck de­cision of the European...
On 8 Septem­ber 2016, the Gen­er­al Court of the EU ad­op­ted for the first time a judg­ment in a pay-for-delay case in the phar­ma­ceut­ic­al in­dustry. The Court thereby con­firmed the de­cision of the European Com­mis­sion of 19 June 2013 whereby it im­posed a total fine.
30/08/2016
EU Com­mis­sion re­leases draft Pri­vacy Code of Con­duct for mHealth apps
The European Com­mis­sion has draf­ted a code of con­duct on pri­vacy for mo­bile health (mHealth) apps (the “Code”). The Code has been sub­mit­ted to the Art­icle 29 Data Pro­tec­tion Work­ing Group for ap­prov­al.
05/07/2016
Leg­al de­vel­op­ments in product li­ab­il­ity: With re­strict­ive le­gis­la­tion...
The med­ic­al in­dustry is un­der in­creas­ing leg­al pres­sure these days ow­ing mainly to a con­sumer-friendly risk en­vir­on­ment. This is evid­ent from re­strict­ive le­gis­la­tion and re­cent land­mark cases, such as the PIP case, con­cern­ing a French com­pany that sup­plied.